Postpartum DepressionNCT04485000
Online 1-Day CBT-Based Workshops for PPD
A study testing Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
Trial summary
Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2020to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- infant under 12 months old
- EPDS score 10 or more
- Fluent in written/spoken English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online 1-Day CBT-Based Workshops for Postpartum Depression
Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 388 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).
Read the detailed description
The COVID-19 pandemic has further exposed the vulnerabilities in social and economic systems that lead to inequalities for mothers with mental health problems and their children, worsening unintended systematic biases that exist within the healthcare system. These women have been among the most affected by the pandemic, experiencing substantial worry, isolation, loneliness, lack of control, and insomnia (1), all of which have increased PPD rates. They also have more responsibilities than ever before, providing care to their infants, toddlers, and older children, while managing their households and supporting their partners. They are also profoundly worried about job losses, reduced income, and food insecurity , all of which have disrupted family routines, increased partner conflict, and rates of intimate partner violence (2).
Postpartum depression (PPD) typically affects up to 1 in 5 women (3-5), increasing the risk of later depressive episodes (6), parenting problems (7), poor mother-infant attachment (8), and emotional, behavioural, and school problems in offspring (9,10). A single case of PPD has been estimated to cost as much as $150,000 over the lifespan (11), or $57 billion for each annual cohort of Canadian births. Even under ideal conditions, the healthcare system is poorly equipped to provide care for problems requiring urgent psychotherapy like PPD (e.g., just 1 in 10 women with PPD receive evidence-based care) (12). Barriers to care include women's preference for psychotherapy over medication, a lack of time, and a reluctance to travel to regular appointments (13,14). The healthcare system is now even less able to help these women as public health units that previously supported the mental health of mothers have shifted their priorities to direct COVID response. Moreover, social distancing recommendations aimed at reducing COVID-19 risk have inadvertently increased psychological distress and decreased access to resources that protect against PPD including social and practical support from family, friends, and professionals. The need for safe and accessible PPD treatment is further highlighted by the uptake of recent recommendations (written by the NPI) on managing PPD during COVID-19 which have been read 40,000 times since their posting (12).
Only interventions that are considered safe and that can be rapidly upscaled can have an impact on PPD at the population level during COVID-19 (15). Ideal large-scale interventions for PPD during COVID-19 are not only safe (i.e., delivered online), but are brief, utilize the treatments most preferred by women (i.e., non-pharmacological), easily accessible (i.e., self-referred), provide skills that can be used over the long-term, and delivered in large groups to increase social support. At present time, no interventions exist that meet all of these criteria.
The purpose of this study is to assess if Online 1-Day CBT-Based Workshops for PPD added to care as usual during the COVID-19 pandemic improve PPD more than usual care alone, if the workshops are cost-effective, and if these workshops reduce the impact of the common comorbidities and complications of PPD (anxiety, partner relationship discord, and poorer mother-infant attachment).
388 women who are 18 years or older, have a baby under 1 year old and have an Edinburgh Postnatal Depression Scale (EPDS) score of 10 or more will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control) and changes in depression, anxiety, relationship quality, and mother-infant attachment will be compared.
PPD is a major public health issue that has only increased in scope and impact during COVID-19, and no safe, accessible, scalable solutions exist to tackle the scope of this problem. Only health system interventions like ours that utilize existing infrastructure from a previous RCT of face-to-face workshop delivery can be launched expediently on a large scale to significantly improve the health of Canadian women with PPD and their families during this pandemic.
Promising data from a face-to-face trial, and very encouraging recruitment and feasibility findings from the online adaptation of these workshops suggest that self-referred Online 1-Day CBT-Based Workshops can be delivered immediately and rapidly scaled to reduce the impact of COVID-19 on women with PPD and their families. Since the pandemic will have a lasting impact on the delivery of mental healthcare, these online workshops could represent a significant component of the next successfully implemented, research-enabled Canadian public health strategy, and will be applicable globally.
- Conditions
- Postpartum Depression
- Being tested
- Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online 1-Day Cognitive Behavioural Therapy (CBT)-Based WorkshopBehavioural
The workshop is a day-long intervention delivered in 4 modules based on Cognitive Behavioural Therapy (CBT). The workshop covers PPD etiology, modifiable cognitive risk factors, cognitive skills, behavioural skills, problem solving, goal setting and action planning. Each participant is given a professionally designed manual to facilitate learning. Weekly reminder emails are sent for 6 weeks after the workshop completion to encourage practice. A list of PPD resources and a copy of the Canadian Treatment Guidelines for Postpartum Depression are provided.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | The experimental (immediate workshop) group will receive the online workshop at baseline (T1) in addition to receiving standard postnatal care. Receives: Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop |
| Waitlist Cpntrol | Other | The waitlist control group will receive standard postnatal care for 12 weeks and will participate in the online 1-day CBT-based workshop at T2 (12 weeks post baseline). Receives: Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS)
The gold standard measure of PPD in clinical practice/research. Produces a score of 0-30, with higher scores indicating more severe depressive symptoms. A change of 4 points is recognized as a clinically meaningful/significant improvement.
Measured: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.
Secondary outcomes (2)
Cost-effectiveness: Costs of service
Healthcare resource utilization data will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form adapted for the postpartum period and used in previous PPD research. Costs will be calculated using provincial or other standard billing rates.
Measured: Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.
Cost-effectiveness: Quality-Adjusted Life Year (QALY)
The EQ-5D-5L, a utility-based health-related quality of life instrument will be used. Its validity in measuring the impact of depression is established. Its Canadian scoring algorithm will be used. For each participant, a QALY will be calculated by multiplying the health utility for the matching time period (i.e., the area under the curve approach).
Measured: QALYs will be measured over the 12-week trial period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Apr 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Van Lieshout, MD, PhD, McMaster University
- Investigators
- Ryan Van Lieshout, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485000
- Sponsor's protocol ID
- ONLINE1DAYCBT
- Status last verified
- Feb 2021
- First submitted
- 21 Jul 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George KV, Savoy CD, Layton H, Bieling PJ, Van Lieshout RJ. Prevalence of Comorbid Postpartum Depression and Anxiety in Birthing Parents Seeking Treatment for Postpartum Depression: Prevalence de la presence comorbide de la depression et de l'anxiete post-partum chez les parents ayant accouche qui ont consulte en raison de la depression post-partum. Can J Psychiatry. 2026 Jul 1:7067437261462698. doi: 10.1177/07067437261462698. Online ahead of print.
PubMed 42383885Van Lieshout RJ, Layton H, Savoy CD, Brown JSL, Ferro MA, Streiner DL, Bieling PJ, Feller A, Hanna S. Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1200-1207. doi: 10.1001/jamapsychiatry.2021.2488.
PubMed 34495285Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.
PubMed 34232578
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online 1-Day CBT-Based Workshops for Postpartum Depression
- ClinicalTrials.gov ID
- NCT04485000
- Acronym / sponsor ID
- ONLINE1DAYCBT
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 388 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).
Detailed description
The COVID-19 pandemic has further exposed the vulnerabilities in social and economic systems that lead to inequalities for mothers with mental health problems and their children, worsening unintended systematic biases that exist within the healthcare system. These women have been among the most affected by the pandemic, experiencing substantial worry, isolation, loneliness, lack of control, and insomnia (1), all of which have increased PPD rates. They also have more responsibilities than ever before, providing care to their infants, toddlers, and older children, while managing their households and supporting their partners. They are also profoundly worried about job losses, reduced income, and food insecurity , all of which have disrupted family routines, increased partner conflict, and rates of intimate partner violence (2).
Postpartum depression (PPD) typically affects up to 1 in 5 women (3-5), increasing the risk of later depressive episodes (6), parenting problems (7), poor mother-infant attachment (8), and emotional, behavioural, and school problems in offspring (9,10). A single case of PPD has been estimated to cost as much as $150,000 over the lifespan (11), or $57 billion for each annual cohort of Canadian births. Even under ideal conditions, the healthcare system is poorly equipped to provide care for problems requiring urgent psychotherapy like PPD (e.g., just 1 in 10 women with PPD receive evidence-based care) (12). Barriers to care include women's preference for psychotherapy over medication, a lack of time, and a reluctance to travel to regular appointments (13,14). The healthcare system is now even less able to help these women as public health units that previously supported the mental health of mothers have shifted their priorities to direct COVID response. Moreover, social distancing recommendations aimed at reducing COVID-19 risk have inadvertently increased psychological distress and decreased access to resources that protect against PPD including social and practical support from family, friends, and professionals. The need for safe and accessible PPD treatment is further highlighted by the uptake of recent recommendations (written by the NPI) on managing PPD during COVID-19 which have been read 40,000 times since their posting (12).
Only interventions that are considered safe and that can be rapidly upscaled can have an impact on PPD at the population level during COVID-19 (15). Ideal large-scale interventions for PPD during COVID-19 are not only safe (i.e., delivered online), but are brief, utilize the treatments most preferred by women (i.e., non-pharmacological), easily accessible (i.e., self-referred), provide skills that can be used over the long-term, and delivered in large groups to increase social support. At present time, no interventions exist that meet all of these criteria.
The purpose of this study is to assess if Online 1-Day CBT-Based Workshops for PPD added to care as usual during the COVID-19 pandemic improve PPD more than usual care alone, if the workshops are cost-effective, and if these workshops reduce the impact of the common comorbidities and complications of PPD (anxiety, partner relationship discord, and poorer mother-infant attachment).
388 women who are 18 years or older, have a baby under 1 year old and have an Edinburgh Postnatal Depression Scale (EPDS) score of 10 or more will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control) and changes in depression, anxiety, relationship quality, and mother-infant attachment will be compared.
PPD is a major public health issue that has only increased in scope and impact during COVID-19, and no safe, accessible, scalable solutions exist to tackle the scope of this problem. Only health system interventions like ours that utilize existing infrastructure from a previous RCT of face-to-face workshop delivery can be launched expediently on a large scale to significantly improve the health of Canadian women with PPD and their families during this pandemic.
Promising data from a face-to-face trial, and very encouraging recruitment and feasibility findings from the online adaptation of these workshops suggest that self-referred Online 1-Day CBT-Based Workshops can be delivered immediately and rapidly scaled to reduce the impact of COVID-19 on women with PPD and their families. Since the pandemic will have a lasting impact on the delivery of mental healthcare, these online workshops could represent a significant component of the next successfully implemented, research-enabled Canadian public health strategy, and will be applicable globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based WorkshopThe experimental (immediate workshop) group will receive the online workshop at baseline (T1) in addition to receiving standard postnatal care. |
| Waitlist Cpntrol | Other | Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based WorkshopThe waitlist control group will receive standard postnatal care for 12 weeks and will participate in the online 1-day CBT-based workshop at T2 (12 weeks post baseline). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- infant under 12 months old
- EPDS score 10 or more
- Fluent in written/spoken English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online 1-Day Cognitive Behavioural Therapy (CBT)-Based WorkshopThe workshop is a day-long intervention delivered in 4 modules based on Cognitive Behavioural Therapy (CBT). The workshop covers PPD etiology, modifiable cognitive risk factors, cognitive skills, behavioural skills, problem solving, goal setting and action planning. Each participant is given a professionally designed manual to facilitate learning. Weekly reminder emails are sent for 6 weeks after the workshop completion to encourage practice. A list of PPD resources and a copy of the Canadian Treatment Guidelines for Postpartum Depression are provided. | Behavioural | Immediate Treatment, Waitlist Cpntrol |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.
The gold standard measure of PPD in clinical practice/research. Produces a score of 0-30, with higher scores indicating more severe depressive symptoms. A change of 4 points is recognized as a clinically meaningful/significant improvement.
2 secondary outcomes
Cost-effectiveness: Costs of service
Time frame: Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.
Cost-effectiveness: Quality-Adjusted Life Year (QALY)
Time frame: QALYs will be measured over the 12-week trial period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 42383885George KV, Savoy CD, Layton H, Bieling PJ, Van Lieshout RJ. Prevalence of Comorbid Postpartum Depression and Anxiety in Birthing Parents Seeking Treatment for Postpartum Depression: Prevalence de la presence comorbide de la depression et de l'anxiete post-partum chez les parents ayant accouche qui ont consulte en raison de la depression post-partum. Can J Psychiatry. 2026 Jul 1:7067437261462698. doi: 10.1177/07067437261462698. Online ahead of print.
- Derived from this study: PubMed 34495285Van Lieshout RJ, Layton H, Savoy CD, Brown JSL, Ferro MA, Streiner DL, Bieling PJ, Feller A, Hanna S. Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1200-1207. doi: 10.1001/jamapsychiatry.2021.2488.
- Derived from this study: PubMed 34232578Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Van Lieshout, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) (time frame: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485000, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.